Interactive Sensor Technology to Measure Adherence to Prescribed Therapeutic Foot

描述(申请人提供)：处方鞋，如可拆卸石膏步行器，用于减少对脚底的有害压力，以预防和治疗糖尿病足部溃疡(DFU)。虽然这是治疗和预防DFU的关键组成部分，但根据患者访谈和最初的客观评估，患者对这些设备的依从性非常差。使用“现成”活动监测器客观监测粘连情况提供了一些关于粘连和伤口愈合的有价值的信息，然而，迄今为止使用的方法有几个重大限制，不适合在研究环境之外使用。这种方法仅限于评估行走过程中的足部负荷，因此忽略了站立时足部的显著负荷。此外，也无法识别传感器是否被佩戴，从而大大低估了活动/粘附值。最后，从这些设备计算依从性是相当费力的，并且不能实时完成。在这项提案中，我们开发了一种创新的低成本技术，通过向患者发送警报通知和向临床医生提供有价值的数据记录器信息来帮助提高患者的依从性。拟议的系统结合了广泛可用的廉价设备和创新的体力活动监测技术，以提高患者对穿着规定鞋的依从性。该设备包括一个集成在受试者鞋子中的有源RFID标签(射频识别)，以及一个穿戴在身上的传感器，该传感器包括一个RFID标签读取器和基于微电子机械系统(MEMS)技术的运动传感器，用于监测自发的日常身体活动。RFID标签将起到接近传感器的作用，其范围限制在患者身体的长度。因此，要将身体活动归类为符合规定的鞋类，记录活动的MEMS传感器必须同时检测到鞋类处于传感器范围内(例如，正在穿着)。这项建议的技术是我们使用非显眼的身体可穿戴技术实时监测自发日常身体活动的工作的延伸。人体佩戴传感器实时测量特定的身体姿势，如坐、走、站和躺，还能够通过监测呼吸引起的胸部运动来衡量患者佩戴传感器的依从性。该软件算法足够敏感和具体，可以集成警报，如果受试者在没有穿上RFID标签的鞋的情况下行走不安全。(例如，走五步以上)。如果RFID标签超出范围(即受试者没有穿鞋)，传感器单元将通知警报(通过声音或振动)，并在板载存储系统中标记警报时间。在这项研究的临床部分，设计了两种不同的测试，以解决其有效性及其在以下方面的应用：(A)将患者在家中和社区行走时对指定鞋类的依从性与先前的遵守规定鞋类的衡量标准(例如面对面访谈)进行比较，以及(B)调查患者鞋类行为因常用做法而发生的变化，例如解决患者的偏好、患者教育和警报的使用。这项建议的技术可以立即改变糖尿病足的护理管理，并使临床医生能够更好地管理糖尿病伤口护理。它还可以通过改善受试者对处方鞋的坚持和允许每日体力活动的剂量来实现聪明的足部溃疡预防策略。最后，这种设备和它收集的数据也可能成为一种有价值的患者教育工具。

DESCRIPTION (provided by applicant): Prescribed footwear, such as Removable Cast Walkers, are used to reduce harmful pressures on the bottom of the foot for prevention and treatment of diabetic foot ulceration (DFU). Although a key component to the healing and prevention of DFU, patient adherence with these devices is excessively poor as determined by patient interviews and initial objective assessments. The use of "off the shelf" activity monitors for objective monitoring of adherence has provided some valuable information regarding adherence and wound healing, however, the methodology used to date has had several significant restraints and is not suitable for use outside of the research setting. This methodology is limited to the assessment of foot loading during walking and thereby ignores the significant loading of feet that occurs while standing. Also there is no means of identifying whether sensors were worn, allowing for significantly underreported activity/adherence values. Lastly, the calculation of adherence from these devices is quite labor intensive and cannot be done in real time. In this proposal, we develop an innovative and low cost technology that could help improve patient adherence via both an alarm notification to the patient and valuable data logger information provided to clinician. The proposed system combines a widely available inexpensive device with innovative physical activity monitoring technology for improving patients' adherence to wearing prescribed footwear. The device consists of an active RFID tag (Radio-frequency identification) integrated in the subject's footwear, together with a body worn sensor that includes an RFID tag reader and motion sensors based on micro-electro-mechanical systems (MEMS) technology for monitoring spontaneous daily physical activity. The RFID tag will act as a proximity sensor, with the range limited to the length of the patient's body. Therefore for physical activity to be classified as adherent with the prescribed footwear, the MEMS sensor recording the activity must concurrently detect the footwear as being within sensor range (e.g. being worn). The suggested technology is an extension of our work in monitoring spontaneous daily physical activities in real-time using unobtrusive body wearable technology. The body worn sensor measures specific body postures in real-time, such as sitting, walking, standing, and lying down and is also capable of measuring patients' compliance in wearing the sensor by monitoring chest movement due to respiration. The software algorithm is sensitive and specific enough to integrate an alarm, should the subject ambulate unsafely without their RFID tagged footwear. (e.g., walk more than five steps). In case that the RFID tag is out of range (i.e. subject didn't wear the footwear), the sensor unit will notify an alarm (via sound or vibration) and will mark the time of the alarm in the on-board memory system. In the clinical part of the study, two different tests are designed to address its validity as well as its application in (a) quantification of patient adherence as compared to previous measures of adherence to prescribed footwear (e.g. face-to-face interview) while ambulating at home and in the community and (b) investigating changes in patients' footwear behavior in response to commonly used practices, such as addressing patient preferences, patient education; and use of alarm. The suggested technology could make an immediate difference in diabetic foot care management and enable clinicians to better manage diabetic wound care. It may also lead to smart foot ulcer prevention strategies via improving subjects' adherence to prescribed footwear and allowing for dosage of daily physical activity. Lastly this device and the data gathered by it may also serve as a valuable patient education tool.